KARL STORZ Photodynamic D-Light C (PDD) System
FDA premarket approval P050027/S013 · decided 2018-10-23
Approval details
- PMA number
- P050027
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- KARL STORZ Photodynamic D-Light C (PDD) System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2018-07-20
- Decision date
- 2018-10-23
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for the following alternate sterilization methods for the PDD Camera Heads: STERRAD NX Standard Cycle, STERRAD 100 NX Standard and Duo Cycles, V-Pro 60 Non-Lumen and Lumen Cycles.
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